GMP QA Process Specialist — Investigations & Training

Johnson; Italia; In loco; EUR 34.000 - 54.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Descrizione del lavoro

Johnson & Johnson in Latina, Italy, seeks a QA Process Specialist to join the Quality team at Borgo San Michele. You will ensure product compliance with GMP and regulatory standards, review procedures, and work with quality systems to maintain documentation and quality controls.

You will manage investigations, lead escalation, mentor new hires, and support production and quality assurance across the site, interfacing with global functions as needed.

Competenze

• Master’s degree or diploma in a scientific field or equivalent experience in pharma.
• At least 2 years of quality experience in a pharmaceutical company and as an investigator.
• Excellent English language skills; strong MS Office knowledge.

Mansioni

• Manage complex investigations ensuring GMP and regulatory compliance.
• Act as Quality Leader in investigation approvals and strategy definition.
• Lead escalation processes following company procedures.
• Coach new hires in investigation training and coordinate shop floor activities.
• Backup in Quality Oversight for Production and QC, tracking annual plan and improvements.
• Maintain presence in operations and train personnel on new regulations.
• Serve as Quality reference for LCM projects and support NPI as needed.

Conoscenze

Administrative Support

Communication

Compliance Management

Controls Compliance

Execution Focus

ISO 9001

Persistence and Tenacity

Problem Solving

Quality Control (QC)

Quality Control Testing

Quality Standards

Quality Systems Documentation

Quality Validation

Report Writing

Standard Operating Procedure (SOP)

Teamwork

Technologically Savvy

Formazione

Master’s degree or diploma in a scientific field

Strumenti

Microsoft Office

Descrizione del lavoro

Johnson & Johnson in Latina, Italy, seeks a QA Process Specialist to join the Quality team at Borgo San Michele. You will ensure product compliance with GMP and regulatory standards, review procedures, and work with quality systems to maintain documentation and quality controls.

You will manage investigations, lead escalation, mentor new hires, and support production and quality assurance across the site, interfacing with global functions as needed.